The Office of Generic Drugs (OGD) updated its April stats and notes 4 refuse-to-receive (RTR) actions (3 standard ANDAs and 1 priority application) which is in line with what we have seen so far this entire FY (months average for 7 months is 3.6 RTRs/month). OGD also acknowledged 65 new ANDAs in April.
Of the 65 ANDAs approved actions in April, 12 were approved in the first cycle (just over 18%) which is an improvement over most months. For the first 7 months of reporting of this metric, the percentage of first cycle approval is 17.8%. On the tentative approval actions side of the 22 TAs issued, only 1 was completed in the first review cycle.
Information requests were consistent with other months, but discipline review letters hit a FY 2020 high of 230. And while most other updated statistics were also in line with other months, CBE supplements ballooned to a record 944 for the FY (previous high was 845 in December 2020).
The official May ANDA full approval actions were at 63 and TA approval actions numbered 12 for a total of 75 approval actions during that month. OGD reported issuing only 149 complete response letters, the lowest for the FY so far, and OGD received 68 new ANDA submissions.
As promised, in my post of June 3rd, here are the projected full FY 2020 totals based on the currently reported 8 month data for the following metrics:
Full approval actions estimate 700
Tentative approvals estimate 169
New ANDAs received estimate 906
At the current pace, it appears that full approval and tentative approval actions will be lower than FY 2019 (935 and 236, respectively) and new ANDA receipts will be higher than that of FY 2019, which came in at 909, which would mean that ANDA receipts would be greater than full approvals. All data is derived from the Generic Drugs Program Activities Report – Monthly Performance Fiscal Year 2020, which can be found here.
We will keep updating the FY estimates each month through the end of the FY.
*please note that the original post had some calculation errors, for which we apologize